International regulatory

What the US and the EU ask for, prepared from the design file you already hold rather than rebuilt market by market.

When international regulatory work is the right step

When a device is headed for the US or the EU. Each market sets its own class and route, so the plan is made per market, from the same design file.

Enter the US market
A 510(k) premarket notification against a predicate device, or a De Novo or PMA route where no predicate fits.
Enter the EU market
Technical documentation under EU MDR 2017/745, for a notified body review or for self-declaration where the class allows it.
Choose the markets and their order
A regulatory strategy that compares class, route and evidence in each market before you commit.

What you bring, and what you get back

You bring

Intended use and target markets
The design history file and the risk file
Test reports, including accredited lab reports
Clinical data or literature, if any
Candidate predicate devices, if known

You get back

Regulatory strategy per market
Classification in each market
EU technical documentation
510(k) submission content
Draft answers to reviewer questions

One device, a different class in each market

The US uses Class I to III, the EU uses Class I, IIa, IIb and III, and India uses Class A to D. The rules behind each are different, so a class in one market does not carry over to another. The class sets the route: in the US, a 510(k), De Novo or PMA; in the EU, whether a notified body must review the device. Classify in every target market before you plan tests, because each route can need different evidence.

How international regulatory work runs

Step 1
Classify in each market
The class of the device in every market you are aiming at.
Step 2
Choose the route
510(k), De Novo or PMA in the US; the notified body route in the EU.
Step 3
Compile
The technical documentation or submission, from the design file.
Step 4
Support the review
Answers to the regulator's or the notified body's questions.

Questions clients ask

What is a predicate device?

A legally marketed US device that yours is compared with in a 510(k). You show substantial equivalence: the same intended use, and the same technology or differences that raise no new questions of safety and effectiveness.

Does every EU device need a notified body?

No. Most Class I devices are self-declared by the manufacturer. Class I devices that are sterile, have a measuring function or are reusable surgical instruments, and all Class IIa, IIb and III devices, need a notified body.

Can our test reports be used in the US and the EU?

Often, if the lab is accredited and the test follows the version of the standard the regulator recognises. Check the version and the accreditation before testing, not after.

Is ISO 13485 enough for the US and the EU?

It is the basis of the quality system in both, but not the whole of it. Each market adds its own requirements, such as post-market surveillance in the EU and adverse event reporting in the US. See India, US and EU routes.

Two engineers reviewing documents on a monitor

One design file, several markets

Our two sites are certified to ISO 13485. The technical documentation and the 510(k) content are compiled from the same design file that feeds the India dossier.

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